To learn the applications of Good Clinical Practice (GCP) in clinical research.
ICH-Good Clinical Practice Guidelines are international standards of ethical and scientific consistency for the preparation, implementation, monitoring, evaluation, analysis, review and reporting of biomedical and behavioral research in the human population. Good clinical practice provides a framework of principles aimed at ensuring the safety of research participants and the integrity and validity of the data. The guideline came into force in 1997 as a guide by a steering group called the Tripartite International Harmonization Council (ICH) which included the regulatory agencies of the three major regions referred to above.
It is compulsory and necessary for a person to undergo training on the Good Clinical Practice guidelines (GCP) before taking part in any clinical research operation. The Professional Certificate in Advanced Good Clinical Practices (GCP) course is designed to prepare clinical research personnel in accordance with the applicable Good Clinical Practice (GCP) guidelines. This on-line training program is covered by 12 quality course modules to do so in-depth training on the ICH-GCP guidelines and related clinical research procedures.
Module 1: Introduction to Clinical Research
Module 2: Evolution of ICH-GCP
Module 3: GCP Guidelines and Code of Federal Regulations (CFR)
Module 4: Roles and Responsibilities
Module 5: Institutional Review Board (IRB)
Module 6: Informed Consent
Module 7: Study Subject Recruitment and Retention
Module 8: Safety Reporting and Adverse Event Management
Module 9: Monitoring and Quality Assurance
Module 10: Research Protocol
Module 11: Essential Research Documents
Module 12: Research Misconduct
Clinical Trials Terminology
Assessment through Online Exam
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Length: 4 weeks
Timings: Self Paced
Effort: 55 hrs. approx
Skill Level: All